Medical device positioning system

ABSTRACT

Embodiments of the invention include a medical device for accessing a patient&#39;s body portion and used for diagnosis and treatment of medical conditions. Embodiments of the invention may include a particular endoscopic positioning mechanism for placing an endoscope and an additional treatment device within desired body portions in order to assist in diagnosis and treatment of anatomical diseases and disorders. In particular, a medical device according to an embodiment of the invention may include an outer flexible tube and a positioning mechanism configured for rotating one portion of the flexible tube relative to another portion of the flexible tube.

FIELD OF THE INVENTION

The invention relates to an endoscope system for accessing a patient'sbody portion and used for diagnosis and treatment of medical conditions.For example, embodiments of the invention may include a particularendoscopic positioning mechanism for placing an endoscope and anadditional treatment device within desired body portions in order toassist in diagnosis and treatment of anatomical diseases and disorders.

BACKGROUND OF THE INVENTION

Endoscopes for medical use have been adopted for various diagnostic andmedical treatment procedures. Endoscopes have been used for thediagnosis and treatment of a wide range of diseases and disorders thatoften require a physician to access the tortuous and relatively smallcross-sectional areas of a patient's internal anatomical body lumens. Apatient's pancreaticobiliary system (including the anatomical regions ofthe gall bladder, pancreas, and the biliary tree), for example, isaccessed for diagnosis, and/or treatment of disorders of certainportions of the digestive system.

During treatment of the digestive system, endoscopes are often used toaccess and visualize a patient's pancreaticobiliary system. Once theendoscope is positioned in the desired body portion, a treatmentinstrument can be advanced through the working channel of the endoscopeto the desired body portion. The endoscope and treatment instrument maythen be manipulated as desired for visualization and treatmentrespectively.

Endoscopic retrograde cholangiopancreatography (ERCP) is one example ofa medical procedure that uses an endoscope. ERCP enables the physicianto diagnose problems in the liver, gallbladder, bile ducts, andpancreas. The liver is a large organ that, among other things, makes aliquid called bile that helps with digestion. The gallbladder is asmall, pear-shaped organ that stores bile until it is needed fordigestion. The bile ducts are tubes that carry bile from the liver tothe gallbladder and small intestine. These ducts are sometimes calledthe biliary tree. The pancreas is a large gland that produces chemicalsthat help with digestion and hormones such as insulin.

The biliary system delivers bile produced by the liver to the duodenumwhere the bile assists other gastric fluids in digesting food. Thebiliary system includes the liver, as well as a plurality of bodilychannels and organs that are disposed between the liver and theduodenum. Within the liver lobules, there are many fine “bile canals”that receive secretions from the hepatic cells. The canals ofneighboring lobules unite to form larger ducts, and these converge tobecome the “hepatic ducts.” They merge, in turn, to form the “commonhepatic duct.” The “common bile duct” is formed by the union of thecommon hepatic and the cystic ducts. It leads to the duodenum, where itsexit is guarded by a sphincter muscle. This sphincter normally remainscontracted until the bile is needed, so that bile collects in the commonbile duct and backs up to the cystic duct. When this happens, the bileflows into the gallbladder and is stored there.

ERCP is used primarily to diagnose and treat conditions of the bileducts, including gallstones, inflammatory strictures (scars), leaks(from trauma and surgery), and cancer. ERCP combines the use of x-raysand an endoscope. Through the endoscope, the physician can see theinside of the stomach and duodenum, and inject dyes into the ducts inthe biliary tree and pancreas so they can be seen on x-rays.

An ERCP is performed primarily to identify and/or correct a problem inthe bile ducts or pancreas. For example, if a gallstone is found duringthe exam, it can often be removed by means of a treatment instrument,eliminating the need for major surgery. If a blockage in the bile ductcauses yellow jaundice or pain, it can be relieved through the use of atreatment instrument inserted through the endoscope.

Since endoscopes are often used to access the tortuous and relativelysmall cross-sectional areas of a patient's internal anatomical bodylumens, repeated manipulation and positioning of an endoscope during amedical procedure can cause problematic side-effects. For example,repeated manipulation and positioning of the endoscope can causeunnecessary trauma to a patient's internal tissues. Improper placementand repeated attempts to access a desired treatment region canexacerbate tissue trauma as well as unnecessarily prolong the medicalprocedure. According, there is a need for more precise endoscopemanipulation as well as manipulating an underlying treatment instrumentthrough an access channel of an endoscope.

Thus, it is desirable to have an endoscope assembly that can moreprecisely access the tortuous and relatively small cross-sectional areasof certain anatomical body lumens, and more precisely manipulate atreatment device provided within an access channel of an endoscope.

SUMMARY OF THE INVENTION

Embodiments of the present invention are directed to an improvedendoscope system and a positioning device for manipulating a treatmentdevice that obviates one or more of the limitations and disadvantages ofprior medical devices.

In one embodiment, a medical device comprises an elongated flexible tubedefining a longitudinal axis and including a proximal portion and adistal portion connected to the proximal portion by a joint. Theflexible tube defines a lumen extending through the proximal portion andthe distal portion and leading to an opening at the distal end of theflexible tube. The distal portion rotates relative to the proximalportion.

In various embodiments, the device may include one or more of thefollowing additional features: wherein the opening is disposed along anexterior side surface of the distal portion, and the lumen extendsdistally within the distal portion and curves to terminate at theopening; wherein the lumen is configured to receive a treatmentinstrument therein that can extend through the opening during a medicalprocedure; wherein the lumen is configured to receive a treatmentinstrument therein that can extend through the opening when the distalportion is rotated relative to the proximal portion; wherein the jointcomprises a bearing; wherein the joint is more flexible than both thedistal and proximal portions of the flexible tube; wherein a secondlumen is defined within the proximal portion and houses a torquetransfer element therein; wherein a cavity is defined within the distalportion and extends distally within the distal portion, the cavityreceiving a distal portion of the torque transfer element that extendsdistally beyond the second lumen; wherein the torque transfer elementcomprises a shaft extending distally to a gear arrangement in the distalportion, such that when torque is applied to the shaft, rotary motion istransferred to rotate the distal portion relative to the proximalportion; wherein rotation of the torque transfer element transmitsrotary motion to the distal portion, and wherein the cavity is sized topermit rotation of the distal portion in an amount less than 360 degreesrelative to the proximal portion; wherein the cavity exhibits an arcshape having a constant radius of curvature such that during rotation ofthe distal portion, the torque transfer element remains spaced aconstant distance from a center of the elongated flexible tube; whereinstops bound the cavity to prevent rotation of the distal portion beyonda predetermined angle; wherein the lumen of the proximal portion iscentrally located within the proximal portion; wherein a distal end ofthe lumen in the proximal portion communicates with a proximal portionof the lumen in the distal portion; wherein the lumen in the proximalportion communicates with the lumen in the distal portion through anaperture within the joint; wherein a proximal portion of the lumen ofthe distal portion is centrally located within the distal portion;wherein visualization and illumination components are provided withinthe lumen of the proximal portion and the distal portion; wherein thejoint comprises a planetary gear system; wherein the planetary gearsystem includes a sun gear, at least one planet gear, a ring gear, and acarrier, wherein an exterior surface of the ring gear forms an exteriorsurface of the joint along an exterior surface of the medical device;wherein the joint is integrated with the distal portion; wherein thelumen of the flexible tube extends through an aperture provided throughthe planetary gear system; wherein the sun gear is grounded throughconnection to the proximal portion such that rotation of the carrierresults in rotation of the ring gear and the distal portion; wherein thecarrier is grounded through connection to the proximal portion such thatrotation of the sun gear results in rotation of the ring gear and thedistal portion; wherein the planetary gear system is configured torotate the distal portion relative to the proximal portion through atleast 360 degrees; wherein the joint is comprised of a helical grooveprovided on an interior surface of the proximal portion and anengagement pin provided on the distal portion, the engagement pin beingconfigured for engagement with the helical groove such that forwarddisplacement of the distal portion relative to the proximal portionresults in rotation of the distal portion relative to the proximalportion; wherein the helical groove terminates at a proximal end in alinear groove provided on an interior surface of the proximal portion;wherein the linear groove terminates in an engagement section configuredto releasably engage the engagement pin; wherein the engagement sectioncomprises an interference fit connection; wherein the distal portion isconfigured to rotate relative to the proximal portion through at least360 degrees; wherein rotation of the distal portion relative to theproximal portion is limited to a range of about 0-30 degrees; andwherein rotation of the distal portion relative to the proximal portionis limited to a range of about 0-20 degrees.

Another embodiment is directed to a method of positioning a treatmentinstrument in a body. The method comprises providing a medical devicecomprising: an elongated flexible tube defining a longitudinal axis andincluding a distal end and a proximal end, the flexible tube including aproximal portion and a distal portion connected to the proximal portionby a joint. The flexible tube defines a lumen extending through theproximal portion and the distal portion and leading to an opening at thedistal end of the flexible tube. The method further includes insertingthe medical device into an anatomical lumen of the body; inserting atreatment instrument through the lumen of the proximal portion andthrough the lumen of the distal portion; and positioning the treatmentinstrument by rotating the distal portion relative to the proximalportion.

In various embodiments, the method may include one or more of thefollowing additional features: extending the treatment instrumentthrough the lumen of the distal portion and out of the opening of themedical device into the anatomical lumen; wherein the medical devicehouses a shaft for transferring rotary motion to the distal portion suchthat when torque is applied to shaft, rotary motion is transferred torotate the distal portion relative to the proximal portion; retractingthe treatment instrument into the medical device, repositioning themedical device within the anatomical lumen, applying torque to the shaftto rotate the distal portion, and extending the treatment instrumentthrough the opening; wherein the treatment instrument is positionedwithin a bile duct during an ERCP procedure; wherein the joint comprisesa bearing; wherein the distal portion is rotated 180 degrees relative tothe proximal portion; wherein the opening is disposed along an exteriorside surface of the distal portion, and the lumen extends distallywithin the distal portion and curves to terminate at the opening;wherein the joint is more flexible than both the distal and proximalportions of the flexible tube; wherein the lumen of the proximal portionis centrally located within the proximal portion; wherein a distal endof the lumen in the proximal portion communicates with a proximalportion of the lumen in the distal portion; wherein the lumen in theproximal portion communicates with the lumen in the distal portionthrough an aperture within the joint; wherein a proximal portion of thelumen of the distal portion is centrally located within the distalportion; wherein a second lumen is defined within the proximal portionand houses a torque transfer element therein and wherein a cavity isdefined within the distal portion and extends distally within the distalportion, the cavity receiving a distal portion of the torque transferelement that extends distally beyond the second lumen; wherein rotationof the torque transfer element transmits rotary motion to the distalportion, and wherein the cavity is sized to permit rotation of thedistal portion in an amount less than 360 degrees relative to theproximal portion; wherein the cavity exhibits an arc shape having aconstant radius of curvature such that during rotation of the distalportion, the torque transfer element remains spaced a constant distancefrom a center of the elongated flexible tube; wherein stops bound thecavity to prevent rotation of the distal portion beyond a predeterminedangle; wherein the joint comprises a planetary gear system including asun gear, at least one planet gear, a ring gear, and a carrier, andwherein rotating the distal portion relative to the proximal portioncomprises rotating the sun gear relative to the carrier; wherein thejoint comprises a planetary gear system including a sun gear, at leastone planet gear, a ring gear, and a carrier, and wherein rotating thedistal portion relative to the proximal portion comprises rotating thecarrier relative to the sun gear; and wherein the joint is comprised ofa helical groove provided on an interior surface of the proximal portionand an engagement pin provided on the distal portion, the engagement pinbeing configured for engagement with the helical groove and whereinrotating the distal portion relative to the proximal portion comprisesforwardly displacing the distal portion relative to the proximalportion.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a prior art endoscope system.

FIG. 2 is cross-sectional view of a distal portion of an endoscopeaccording to an embodiment of the present invention.

FIG. 3 is a perspective view of components of an endoscope positioningmechanism according to an embodiment of the present invention.

FIG. 4 is a cross-sectional view of an endoscope taken along line 4-4 inFIG. 2.

FIG. 5 is a cross-sectional view of an endoscope taken along line 5-5 inFIG. 2.

FIG. 6A is a perspective view of a distal part of an endoscope accordingto an embodiment of the present invention.

FIG. 6B is a perspective view of a distal part of an endoscope accordingto an embodiment of the present invention.

FIG. 7 illustrates a cross-sectional view of a joint in an endoscopepositioning mechanism, according to another embodiment of the invention.

FIG. 8A depicts a partially exploded perspective view of a distal andproximal portion of an endoscope positioning mechanism, according toanother embodiment of the invention.

FIG. 8B depicts a side view of an assembled endoscope from FIG. 8Aillustrated prior to rotation of a rotating portion.

FIG. 8C depicts a side view of an assembled endoscope from FIG. 8Aillustrated during rotation of a rotating portion.

FIG. 9 illustrates the positioning of an endoscope and treatment devicewithin a patient's body portion.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts. The drawingfigures of this application are intended to provide a generalunderstanding of the working elements of the underlying system.Accordingly, unless explicitly stated, the figures do not represent aliteral depiction of proportional dimensions or the precise locationsfor the illustrated inter-related components.

According to exemplary embodiments, the invention relates to a medicaldevice for positioning a treatment device and/or viewing a patient'sinternal body portion. In embodiments that use a treatment device in anendoscopic medical procedure, the treatment device can be advancedthrough a working channel of an endoscope, including an endoscopespecifically designed and/or sized for use with the treatment device,and into a tissue tract. For purposes of this disclosure, “treatmentdevice” or “treatment instrument” includes, for example, any workingmedical device advanced through a working channel of an endoscope andfor use during an endoscopic procedure. Exemplary treatment instrumentsinclude, but are not limited to, guide wires, cutting or graspingforceps, biopsy devices, snare loops, injection needles, cutting blades,scissors, retractable baskets, retrieval devices, ablation and/orelectrophysiology catheters, stent placement devices, surgical staplingdevices, and balloon catheters.

FIG. 1 illustrates a known endoscope system. For purposes of thisdisclosure, “distal” refers to the end further from the device operatorduring use and “proximal” refers to the end closer to the deviceoperator during use. FIG. 1 depicts an endoscope 10 including a flexibleouter tube 12 extending between a distal end 14 and a proximal end 16 ofthe device. Endoscope 10 includes a treatment device insertion port 11for receiving a treatment device 20 into a working channel of theendoscope 10. The distal end 14 of the endoscope system 10 includes aside facing operation window 18 that can include visualization andlighting components for viewing during a treatment procedure. Inaddition, a working channel (not shown) extends within the endoscope 10and terminates at the operation window 18, thereby allowing thetreatment instrument 20 to be extended from the distal end of theendoscope 10. The extension of the treatment instrument 20 at a desiredtreatment site can be then be viewed through the visualizationcomponents, which transmit images to the proximal end of the endoscope10, as in known in the art. While FIG. 1 illustrates a side facingoperation window 18, both front/forward facing and oblique/intermediateangled windows are known.

FIG. 2 illustrates a cross-sectional view of a distal portion of anendoscope system 10′ according to an exemplary embodiment. Endoscopesystem 10′ includes an outer flexible tube 12′, which extends distallyfrom a handle (not shown) at the proximal end of the system. A joint 22connects a rotating portion 24 of endoscope 10′ to a remaining proximalportion 26 of the endoscope 10′. Joint 22, for example, can be formed ofan anti-friction bearing mechanism, such as, a roller bearing, a ballbearing mechanism, or a magnetic bearing. Alternatively or additionally,joint 22 may be a portion of tube 12′ that is much more flexible thanthe portions of tube 12′ that comprise portions 24, 26 of endoscope 10′.That flexible joint 22 permits a certain degree of rotation about alongitudinal axis of endoscope 10′ and tube 12′ at joint 22. Forexample, rotation may be up to 270 degrees. In addition, joint 22 may beintegrally manufactured with the other portions 24, 26 of endoscope 10′or joint 22 may be a discrete component that attaches portion 24 toportion 26. As another example, joint 22 could be comprised of anarrangement of two ring gears, one inside the other at joint 22 suchthat external teeth of an internal ring rear engage and transmitrotational force to internal teeth of a complementary external ringgear.

Through this arrangement (e.g., a joint between portions 24 and 26)rotating portion 24 is configured for rotation relative to proximalportion 26. That rotation is about a longitudinal axis of endoscope 10′and tube 12′. Joint 22 should be configured in a fluid-tight arrangementin order to prevent contamination and corrosion of the internalcomponents of endoscope 10′ due to contact within a patient's internalbody fluids.

Other mechanisms may be used for rotating portion 24 relative to portion26. For example, a number of pull wires wrapped around a spool couldrotate portion 24. Additional examples include, but are not limited toelectronic actuators, such as a stepper motor, cam drivers, a worm geararrangement, or a pull wire system comprising a pulley type arrangement.

Although not depicted in the accompanying drawing figures, it iscontemplated that the endoscope 10′ may include known positioningstructure for navigating the endoscope 10′ and a treatment instrumentthrough the tortuous pathways of a patient's internal body portion. Forexample, endoscope 10′ may include pull wires for effectuatingdeflection during positioning and an elevator device for altering theangle at which a treatment instrument exits the endoscope 10′.

The proximal portion 26 of endoscope 10′ includes a central lumen 28within the endoscope 10′, which extends from the proximal end of theendoscope 10′ and terminates at the distal end of proximal portion 26.Rotating portion 24 includes a lumen 30 that connects with central lumen28 of proximal portion 26. Lumen 30 extends distally within rotatingportion 24 and curves to extend laterally, terminating at a side facingoperation window 32. As seen in FIG. 2, operation window 32 is disposedalong an exterior side surface of rotating portion 24. While FIG. 2illustrates a side facing operation window 32, embodiments of theinvention include both oblique/intermediate angled windows and afront/forward facing embodiment where lumen 30 extends distally to aposition offset from the center of the endoscope.

Lumens 28 and 30 of endoscope 10′ are configured to receivevisualization components, such as, for example, known endoscopic imagingelements comprising illumination devices and fiber optic viewingelements for the transfer of images to the proximal end of the endoscopeas known in the art. A portion of lumens 28 and 30 may further comprisean endoscopic working channel for receiving and guiding a treatmentinstrument therethrough. In such embodiments, joint 22 will include ahole 29 that connects lumens 28 and 30 during positioning of endoscope10′ and rotation of rotating portion 24 relative to proximal portion 26.In addition, a portion of operation window 32 can include a workingchannel exit port (see item 56 of FIGS. 6A-6B) through which a treatmentinstrument is extended during a medical procedure.

In some embodiments, the treatment instrument delivered through thisendoscope could be designed for increased flexibility of rotation at adistal end portion, thereby accommodating rotation of the rotatingportion 24 of the endoscope 10′. For example, a distal end portion of atreatment instrument could be provided with a rotatable or twistablecomponent.

As seen in FIGS. 2, 4, and 5, proximal portion 26 includes a rotationcomponent lumen 34 that extends distally to communicate with a rotationcomponent cavity 36 within rotating portion 24. Just as joint 22includes a hole 29 connecting lumens 28 and 30, joint 22 also includesan aperture (not shown) connecting lumen 34 and cavity 36. Rotationcomponent cavity 36 extends distally within rotating portion 24 leadingto a force transfer region 38.

A torque transfer element, such as, for example, flexible drive shaft 40is provided within the rotation component lumen 34 and extends distallythrough cavity 36 terminating at force transfer region 38. The proximalend of drive shaft 40 is connected to any known type of positioningcontrol mechanism at a handle at the proximal end of endoscope 10′ toeffectuate rotation of flexible drive shaft 40.

FIG. 3 illustrates one example of components for a torque transferringmechanism for endoscope 10′. In the example of FIG. 3, the forcetransferring mechanism comprises a spur gear arrangement. Thearrangement includes a gear pair comprising a larger gear 42 havinginternal teeth 44 and a pinion 46 with external teeth 48 connected tothe distal end of the flexible drive shaft 40. External teeth 48 ofpinion 46 mesh with internal teeth 44 of gear 42 such that when torqueis applied to flexible drive shaft 40, rotary motion is transferred toouter larger gear 42. When integrated within the endoscope system 10′,the external surface of gear 42 may form part of the external surface ofthe outer flexible tube 12′ of endoscope 10′. Alternatively, gear 42 maybe embedded within tube 12′. Since gear 42 is integrated with rotatingportion 24, torque applied to the flexible drive shaft 40 withinrotation component lumen 34 effectuates rotation of rotating portion 24relative to proximal portion 26. Therefore, rotation of flexible driveshaft 40 effectuates rotation of rotating portion 24 about thelongitudinal axis of flexible tube 12′.

Since lumens 28 and 30 of endoscope 10′ are configured to receivevisualization components and at least one treatment instrument therein,complete rotation of rotating portion 24 could hinder the properoperation of those components. For example, multiple rotations ofrotating portion 24 about the longitudinal axis of tube 12′ could damagethe internal components due to tangling of the elongated components andextreme amounts of torsion within the components housed in lumens 28 and30. In order to avoid those possible consequences of excessive turning,permitting rotation in an amount less than a full 360 degrees ispreferred. Accordingly, certain structure could be provided within theinternal components of endoscope 10′ in order to prevent rotation beyonda particular predetermined angular threshold.

FIGS. 4 and 5 illustrate one example of an arrangement of internalendoscope components for preventing excessive rotation of rotatingportion 24. FIG. 4 represents a cross-sectional view of endoscope 10′taken along line 4-4 in FIG. 2. As seen in FIG. 4, the cross-section ofrotating portion 24 depicts a portion of lumen 30 coaxially disposedtherein. Rotation component cavity 36 is provided to form an arc shapewithin rotating portion 24. FIG. 4 also depicts the cross-section offlexible drive shaft 40, which extends through the cavity 36. FIG. 5 bycontrast, depicts a cross-sectional view of endoscope 10′ taken alongline 5-5 in FIG. 2. FIG. 5 illustrates a portion of central lumen 28,coaxially disposed within proximal portion 26 of the endoscope 10′. Inaddition, FIG. 5 further depicts rotation component lumen 34, whichhouses flexible drive shaft 40 therein.

Arc shaped rotation component cavity 36 is formed to exhibit a constantradius of curvature. Therefore, every point along the arc shapedrotation component cavity 36 is equidistant from the center of tube 12′of endoscope 10′. Accordingly, when the flexible drive shaft 40 isrotated, first and second ends 52 and 54 of arc shaped rotationcomponent cavity 36 provide a boundary limiting the extent to whichrotating portion 24 is permitted to rotate relative to proximal portion26. In order to prevent an excessive torque transmission or excessivetorsion stored along the flexible drive shaft 10′, markers, or any othertype of indicia, can be provided at the positioning control mechanism todepict the allowable limits of rotation. FIG. 4 shows an exemplaryangular rotation of 180 degrees. Other predetermined angular rotationspermitted by cavity 36 are within the scope of the invention.

With reference to FIGS. 6A and 6B, rotation of rotating portion 24 isillustrated. FIG. 6A depicts rotating portion 24 including side facingoperation window 32 and a working channel exit port 56 through which atreatment instrument 60 is extended. FIG. 6A also illustrates anillumination window 57 and a visualization window 58 for viewing aninternal treatment site during a medical procedure as used in knownendoscope devices. With reference to FIG. 6B, through actuation offlexible drive shaft 40, rotating portion 24 is rotated through aparticular angle about the longitudinal axis of flexible outer tube 12′.Through this rotation, the angular orientation of exit port 56 can beprecisely controlled. Accordingly, in the rotated view of FIG. 6B,neither operation window 32 nor exit port 56 are seen. This manipulationof rotating portion 24 and exit port 56 is advantageous in that preciseangular rotation of exit port 56 is achieved without the unnecessarytissue trauma that may result from repeated manipulation and rotation ofan entire endoscope within a patient's body portion. In addition, thearrangement of joint 22 facilitates the free rotation of portion 24relative to proximal portion 26. Accordingly, inefficient torquetransfer and buildup of torsion along the endoscope 10′ is avoided. Inprior endoscope arrangements where rotation of the distal portion iseffected through rotation of the entire device, improper transfer oftorque from the proximal end to the distal end can lead to an unwinding,or whipping, of the distal end during placement of the endoscope. Suchproblems are avoided by the rotation afforded by the present system.

Other mechanisms may be used for rotating portion 24 relative to portion26. For example, a planetary gear system can be used to permit relativerotation of two endoscope portions. FIG. 7, for example, depicts across-sectional view of a joint 22′ including a planetary geararrangement 90. Joint 22′ is configured for use in any endoscopearrangement including a rotating portion 24 and a proximal portion 26,where rotation of a rotating portion 24 relative to a proximal portion26 is desired (as depicted in FIGS. 6A-6B, for example). For example, anexternal surface 100 of joint 22′ can comprise the external exposedsurface of a portion of the underlying endoscope. More, particularly,the external surface 100 can be integral with, or otherwise united with,a rotating portion 24, such that rotation of external surface 100relative to the proximal portion 26, results in rotation of rotatingportion 24 relative to proximal portion 26.

In one embodiment, a central portion of the planetary gear arrangement90 includes a central aperture 29′ connecting lumens 28 and 30, asdescribed above, during positioning of an endoscope and rotation ofrotating portion 24 relative to proximal portion 26, for example.Accordingly, visualization components and at least one treatmentinstrument extend through aperture 29′ when used in a system comprisedof joint 22′.

With reference to FIG. 7, the planetary gear system includes a centralcog-wheel, called the sun gear 92 having external sun gear teeth 93. Thecentral aperture 29′, described above, extends through sun gear 92. Thesun gear 92 is surrounded by one or more planet gears 94. Each of theplanet gears 94 include planet gear teeth 95 that engage sun gear teeth93. The planet gears 94 also engage internal teeth 96 of an externalring gear 97, also commonly referred to as an annulus. A carrier 98 iscoupled with the planet gears 93. For example, in FIG. 7, twocylindrical prongs 99 of carrier 98 are coupled with each of theillustrated planet gears 93. The central aperture 29′ extends throughcarrier 98 just as it extends through sun gear 92.

In the planetary gear system 90, rotation is transmitted from oneelement to another in the gear network by grounding, also calledlocking, one element (i.e. either the sun gear 93, the ring gear 97, orthe carrier 98) to a stationary component of structure. In an endoscopethat includes joint 22′ for effectuating rotation of a rotating portion24 relative to a proximal portion 26, the locked component of planetarygear system 90 will be connected, or otherwise held stationary relativeto, the proximal portion 26 of the underlying endoscope.

In one embodiment, carrier 98 is grounded by virtue of connection to aproximal portion 26 of the underlying endoscope. As such, carrier 98will not rotate relative to the proximal portion 26. In such anarrangement, rotation of rotating portion 24 can be effectuated throughrotation of sun gear 92 relative to carrier 98. For example, due to theengagement of gear teeth 93, 95, and 96, rotation of sun gear 92 in afirst direction results in concurrent rotation of the planet gears 94and, in turn, ring gear 97, in a second rotational direction oppositethe first direction.

Rotation of sun gear 93 relative to carrier 98 can be effectuatedthrough any known torque transfer element. For example, a hollow,flexible drive shaft (not shown) can be provided within the proximalportion 26 of the underlying endoscope. The proximal end of the driveshaft is then connected to any known type of positioning controlmechanism at a handle at the proximal end of the underlying endoscope.Accordingly, in such an arrangement a user can control rotation ofrotating portion 24 through actuation of a positioning mechanism that inturn results in rotation of sun gear 92.

In another embodiment, sun gear 92 is grounded by virtue of connectionto a proximal portion 26 of the underlying endoscope. As such, sun gear92 will not rotate relative to the proximal portion 26. In such anarrangement, rotation of rotating portion 24 can be effectuated throughrotation of carrier 98 relative to sun gear 92. For example, due to theengagement of gear teeth 93, 95, and 96, rotation of carrier 98 in afirst direction results in rotation of planet gears 94 about the lockedsun gear 92. The movement and rotation of planet gears 94 also resultsin rotation of ring gear 97 in the same direction as carrier 98.

Just as described above with regard to an arrangement where sun gear 92is rotated, rotation of carrier 98 can be effectuated through any knowntorque transfer element. For example, a hollow, flexible drive shaft(not shown) can be provided within the proximal portion 26 of theunderlying endoscope. The proximal end of the drive shaft is thenconnected to any known type of positioning control mechanism at a handleat the proximal end of the underlying endoscope. Accordingly, in such anarrangement, a user can control rotation of rotating portion 24 throughactuation of a positioning mechanism that in turn results in rotation ofcarrier 98.

FIGS. 8A-8C depict another example of a mechanism for rotating arotating endoscope portion relative to a proximal portion. For example,a complementary pin and helical groove arrangement can be used to permitrelative rotation of two endoscope portions. FIG. 8A depicts a partiallyexploded isometric view of two endoscope portions 24′ and 26′respectively. Item 24′ depicts a distal rotating portion of anunderlying endoscope. Just as in the embodiment of FIGS. 6A-6B, rotatingportion 24′ may include an operation window 32′ including a workingchannel exit port 56′. A proximal portion of rotating portion 24′includes a reduced diameter portion 102. The reduced diameter portion102 may also include an engagement pin 104 outwardly radially extendingtherefrom.

Item 26′ depicts a flexible proximal endoscope portion 26′. Proximalportion 26′ can be hollow and configured for rotationally receiving thereduced diameter portion 102 within a distal portion thereof. As seen inFIGS. 8A-8C, an internal surface of proximal portion 26′ may include aninternal helical groove 106 extending therein. In a final configuration,the rotating portion 24′ is received within the proximal portion in afluid tight manner, but one that still allows rotation of rotatingportion 24′ relative to proximal portion 26′. A fluid tight arrangementcan be provided through the use of sealing projections (not shown) alongreduced diameter portion 102, or within the hollow proximal portion 26′.Additionally, or alternatively, a fluid tight arrangement can beprovided through the use of a gasket or o-ring element.

FIG. 8B is a side view of an endoscope arrangement depicting rotatingportion 24′ united with proximal portion 26′. For purposes of clarity,the internal helical groove 106 of proximal portion 26′ is depicted inFIG. 8B. The helical groove 106 extends proximally within proximalportion 26, transitioning into a linear groove 108. Initially, prior torotation of rotating portion 24′, engagement pin 104 of rotating portion24′ is seated within and operatively engaged within the linear groove108 of the proximal portion 26′. In one arrangement, the very proximalend of the groove 108 terminates in a reduced size engagement section109. Prior to rotation of rotating portion 24′, the engagement pin 104is releasably seated at the proximal end of linear groove 108 within theterminal engagement section 109.

The relation between the engagement pin 104 and engagement section 109may be such that the pin 104 is selectively or otherwise releasablefrom, and in certain embodiments re-engagable with, the engagementsection 109. The engagement between pin 104 and engagement section 109may be achieved, for example, by a male/female connection in which aportion of pin 104 is inserted and received within the engagementsection 109, which is of a reduced size configured to releasably receivethe pin 104 by virtue of an interference fit. The engagement may berealized, for example, by a ball and socket type connection, a frictionfit engagement, a screw-like configuration or any other releasableengagement mechanisms known to one having ordinary skill in the art.

Rotation of rotating portion 24′ can be effectuated through controlledmovement of engagement pin 104 within both linear groove 108 and helicalgroove 106. To initiate rotation, the rotating portion 24′ must be movedrelative to the proximal portion 26′ with an initial forwarddisplacement force of a magnitude great enough to overcome the forcewith which engagement section 109 holds pin 104. Rotating portion 24′can be displaced relative to the proximal portion 26′ with any knownforce transfer element. Examples of suitable force transfer elementsinclude, but are not limited to, push wires, stylets, cam drivers,stepper motors, a pull wire arrangement where a pulley type systemchanges a proximal pulling force into a distally directed one, and/orpiezoelectric transducers provided within the proximal portion 26′ ofthe underlying endoscope. When rotation of rotating portion 24′ isdesired, an operator can first linearly displace rotating portion 24′relative to proximal portion 26′ such that engagement pin 104 movesalong linear groove 108 and into the helical groove 106.

As seen in FIG. 8C, once rotating portion 24′ is forwardly displacedsuch that engagement pin 104 enters helical groove 106, continued lineardisplacement results in rotation of rotating portion 24′ relative toproximal portion 26′. FIG. 8C depicts the continued forward displacementof portion 24′ resulting in controlled rotation of rotating portion 24′relative to proximal portion 26′. As seen in FIG. 8C, controlled forwarddisplacement of engagement pin 104 results in rotation of rotatingportion 24′, including operation window 32′. Through the use of a forcetransfer element as described above, the rotating portion 24′ can alsobe returned to the initial configuration where engagement pin 104 isre-engaged with engagement section 109.

While an arrangement comprised of an engagement pin 104 and helicalgroove 106 is described for effectuating rotation of rotating portion24′, other configurations are contemplated. For example, a dovetailprotrusion and complementary groove could also be used. Furthermore, thehelical groove 106 and pin 104 could be reversed such that a pin 104, orother protrusion, is formed on an interior of proximal portion 26′ andwith a helical groove formed on the reduced diameter portion 102 ofrotating portion 24′.

In an alternative arrangement, the location of groove 106 and engagementpin 104 can be reversed. For example, helical groove 106 could beprovided along an exterior surface of reduced diameter portion 102 ofrotating portion 24′ and engagement pin 104 could be provided along aninternal surface of proximal portion 26′. In addition, the rotatingportion 24′ and proximal portion 26′ could be connected and rotatablerelative to each other through any type of mating thread arrangement.

In the particular embodiments of FIGS. 7-8C, rotation of one endoscopeportion relative to another can be achieved in a range even greater that360 degrees, for example. The only limiting factor in suchconfigurations will be the extent to which internal visualizationcomponents and treatment instruments can withstand, or be enabled for,concurrent rotation within internal endoscope lumens in order to resistwinding and kinking due to excessive rotation.

In all embodiments, it is to be understood that the rotation of oneendoscope portion relative to another should protected fromcontamination by structure providing a fluid tight arrangement. Inaddition, the rotation of one portion relative to another can befacilitated by virtue of any lubrication element and or frictionreducing structure. For example, a particular lubricious coating can beprovided along the surfaces where repeated engagement or moving partstakes place.

FIG. 9 illustrates the positioning of an endoscope 10′ and treatmentdevice 60 within a patient's body portion. In particular, FIG. 9 depictsthe extension of a treatment instrument 60 within a particular bile duct80 during an ERCP procedure. As seen in FIG. 9, the endoscope 10′, forexample, is inserted and extended through a patient's stomach 82 suchthat the distal end and exit port 56 (not shown) of endoscope 10′ arepositioned is close relation to a particular bile duct 80 leading to,for example, gall bladder 84. As seen in FIG. 9, treatment instrument 60is extended beyond an internal working channel of endoscope 10′. Theangular direction at which treatment instrument 60 extends fromendoscope 10′ can then be altered, for example, by controlled rotationof rotating portion 24 relative to proximal portion 26 of endoscope 10′.Accordingly, rotation of portion 24 relative to the rest of endoscope10′ repositions the orientation of treatment instrument 60 withoutrequiring rotation of the entire underlying endoscope 10′. Depending onthe particular configuration of the underlying system, rotation of oneendoscope portion relative to another can be up to 360 degrees in someembodiment (such as, for example, the embodiments of FIGS. 7 and 8A-8C).In other embodiments, excessive rotation is unnecessary. For example, insome embodiments rotation is only necessary, and the underlyingstructure can therefore be limited to, within a range of about 0-10degrees, 0-20 degrees, or 0-30 degrees.

During a medical procedure, the exit port 56 along the distal portion ofendoscope 10′ can be repeatedly repositioned at different longitudinallocations within a patient's body. Treatment instrument 60 can then bedeployed at each different location and precisely positioned to access adesired treatment site at that location. Angular adjustment of theorientation of treatment instrument 60 as it extends from endoscope 10′at consecutive treatment locations can reduce internal tissue traumaresulting from repeated rotation of an entire endoscope during atreatment procedure. Furthermore, precise manipulation of a treatmentdevice 60 can result in shortened treatment procedures by reducing theamount of time necessary to effectuate proper position of the treatmentdevice 60.

In addition to the above-described medical device rotation mechanisms,the incorporation of additional positioning mechanisms, includingvarious positioning controls to effectuate bending of the flexible outertube 12′ during a medical procedure, are within the scope of thisinvention. Other embodiments of the invention will be apparent to thoseskilled in the art from consideration of the specification and practiceof the invention disclosed herein. It is intended that the specificationand examples be considered as exemplary only, with a true scope andspirit of the invention being indicated by the following claims.

1. A medical device comprising: an elongated flexible tube defining alongitudinal axis and including a proximal portion and a distal portionconnected to the proximal portion by a joint; wherein the flexible tubedefines a lumen extending through the proximal portion and the distalportion and leading to an opening at a distal end of the flexible tube;and wherein the distal portion rotates relative to the proximal portion.2-52. (canceled)